汉曲优®有望成为首个在中国、欧盟、美国获批的“中国籍”生物类似药；

汉曲优®（欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）现已在全球30余个国家和地区获批上市；

持续拓展海外布局，复宏汉霖将加速为全球患者提供可负担的高品质生物药。

2023年2月14日，复宏汉霖（2696.HK）宣布，公司联合其商务合作伙伴Accord BioPharma Inc.（Accord US）共同推动递交汉曲优®（注射用曲妥珠单抗）在美国的上市许可申请（BLA），并于近日正式获得美国食品药品监督管理局（FDA）受理，拟用于辅助治疗HER2过表达的早期乳腺癌、HER2过表达的转移性乳腺癌，以及HER2过表达的转移性胃腺癌或胃/食管交界处腺癌。2021年，公司与Accord US签署授权许可协议，授予其在美国及加拿大地区对汉曲优®进行独家开发和商业化的权利。

复宏汉霖总裁 朱俊

汉曲优®是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规自主研发的曲妥珠单抗，目前已在全球30多个国家获批上市，累计惠及超过100000位中国患者。此次汉曲优®上市许可申请获美国FDA受理，有望进一步深化公司国际化布局。乳腺癌目前已成为全球发病率最高的肿瘤，曲妥珠单抗是HER2阳性乳腺癌治疗的基石药物。我们期待通过与Accord的合作，让汉曲优®惠及全球更多患者。

汉曲优®为首个中国自主研发的中欧双批单抗药物，于2020年7月及8月先后获得欧盟委员会与中国国家药监局（NMPA）批准上市，用于HER2阳性早期乳腺癌、转移性乳腺癌和转移性胃癌，即涵盖原研已获批准的所有适应症。复宏汉霖针对汉曲优®开展了一系列的头对头比对研究，包括质量对比研究、临床前研究及临床I期和国际多中心临床III期研究等。这些数据充分证明了汉曲优®与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。

复宏汉霖已建立一套符合国际质量标准的质量管理体系，覆盖从项目研发到物料管理、产品生产、质量控制、产品供应链管理以及产品上市后跟踪的全生命周期，为公司产品在多个国家及地区的商业化奠定扎实基础。公司建有徐汇基地、松江基地（一）及松江基地（二）三个生产基地，现有商业化总产能已达48,000升，2026年总产能可达144,000升。2022年，松江基地（一）24,000升产能正式投入汉曲优®商业化生产，有力保障市场持续放量，与拥有24,000升商业化产能的徐汇基地形成协同和规模效应。公司商业化生产基地及配套的质量管理体系已通过NMPA、欧洲药品管理局（EMA）、欧盟质量受权人（QP）以及公司国际商业合作伙伴进行的多项实地核查及审计，获得中国和欧盟药品生产质量管理规范（GMP）认证，可为公司已上市产品提供商业化生产，并已实现中国和欧盟市场常态化供应，强力支撑产品在全球的持续放量。

围绕汉曲优®，复宏汉霖前瞻性地开展了国际商业化布局，积极开拓海外市场，携手全球商业合作伙伴Accord Healthcare、Abbott、Cipla、Eurofarma、Mabxience和雅各臣药业等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球约100个国家和地区。作为国产生物药“出海”代表，汉曲优®（欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip® 和Trastucip®）已于英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯等超过30个国家和地区成功获批上市。随着汉曲优®不断覆盖更多海外国家，复宏汉霖将加速为全球患者提供可负担的高品质生物药。

关于Accord BioPharma

Accord BioPharma是Intas Pharmaceuticals, Ltd.的美国子公司，致力于在肿瘤学、免疫学和重症护理领域提供可负担的、可及的、以患者为中心的疗法。Accord BioPharma致力于于提升体验，超越医学生物学，从患者的角度看待疾病，并开发影响患者生活的高质量疗法。Accord BioPharma的创始人投入时间、热情和资源，专注于专业护理和治疗，积极开发更好的工作方式，并提供更好的治疗方法。如需更多信息，请访问AccordBioPharma.com。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在国际上市1款产品，18项适应症获批，1个上市注册申请获得中国药监局受理，1个上市许可申请获得美国FDA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌和广泛期小细胞肺癌，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，其食管鳞状细胞癌适应症的上市注册申请也正在审评中。公司亦同步就16个产品、12个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02

The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in the U.S. -

HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®) has been approved in more than 30 countries -

As the product footprint expands into more countries, Henlius plans to accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide -

Shanghai, China, February 14, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Henlius’ HLX02 (trastuzumab for injection, trade name in Europe: Zercepac®, trade name in China: HANQUYOU; trade names in Australia: Tuzucip® and Trastucip®) submitted by the company’s business partner Accord BioPharma Inc. (Accord US). The BLA seeks approval of HLX02 for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In 2021, the company granted Accord US the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

Mr. Jason Zhu, President of Henlius, said, "Henlius independently developed HLX02 in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients. The U.S. FDA’s acceptance of the BLA filing not only expands the Henlius’ international footprint. More importantly, we prioritize the needs of patients. As breast cancer has become the most prevalent cancer in the world, trastuzumab has been the cornerstone of treating HER2-positive cases. In collaboration with Accord, we look forward to bringing HLX02 to more patients around the world.”

HLX02 is the first China-developed mAb approved both in China and Europe. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. HLX02 is now indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head to head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results proved that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Henlius has established a quality management system in line with international quality standards, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance, laying the foundation for globalisation. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 litres, and the total production capacity in 2026 is expected to reach 144,000 litres. In 2022, Songjiang First Plant was approved for the commercial production of HLX02 and has been officially put into operation, which effectively ensures market penetration and forms synergy with the Xuhui Facility with a commercial production capacity of 24,000 litres. The company's commercial production facility and supporting quality management system have been certificated by China and the EU GMP. They have also passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person, and multiple international business partners. At the present, a stable supply has been achieved in the Chinese and the EU markets, strongly supporting the continuous expansion of the products globally.

Henlius has aggressively pursued international commercialization of HLX02, actively collaborating with global partners such as Accord Healthcare, Abbott, Cipla, Eurofarma, Mabxience and the Jacobson Group to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to now, HLX02 (trade name in China: HANQUYOU, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®) has launched in over 30 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.

About Accord BioPharma

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies. For more information, Visit AccordBioPharma.com.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 approved for marketing in overseas markets, 18 indications approved worldwide, 1 New Drug Application (NDA) accepted for review in China, and 1 Biologics License Application (BLA) accepted for review in the U.S. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 20 clinical studies for 16 products and 12 immuno-oncology combination therapies, expanding its presence in major markets as well as emerging markets.